System, Fibrinogen Determination
FDA product code KQJ · Class II (moderate risk) · 21 CFR 864.7340 · Hematology
28510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Instrumentation Laboratory CO 2
- Behring Diagnostics, Inc. 2
- Diatech, Inc. 2
- Bio/Data Corp. 2
- Unipath , Ltd. 1
- Instrumentation Laboratory (IL) Co. 1
- Crestat Diagnostics, Inc. 1
- The Binding Site, Ltd. 1
- International Technidyne Corp. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Incstar Corp. 1
- Organon Teknika Corp. 1
- Medical Diagnostic Technologies, Inc. 1
- Helena Laboratories 1
- Wellcome Diagnostics 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- Sherwood Medical Co. 1
- American Dade 1
- Ortho Diagnostic Systems, Inc. 1
- Sigma Chemical Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ · Special | Instrumentation Laboratory (IL) Co. | 07/24/2025SE |
| K073367 | Hemosil Fibrinogen-CKQJ · Special | Instrumentation Laboratory CO | 12/27/2007SE |
| K050928 | Dade Thrombin ReagentKQJ · Traditional | Dade Behring, Inc. | 06/29/2005SE |
| K971858 | Sigma Diagnostics Fibrinogen Kit (886A/887A)KQJ · Traditional | Sigma Diagnostics, Inc. | 10/09/1997SE |
| K970189 | Fif TMKQJ · Traditional | Panbio, Inc. | 05/21/1997SE |
| K965113 | N-Assay Tia Fibrinogen Test KitKQJ · Traditional | Crestat Diagnostics, Inc. | 04/16/1997SE |
| K934326 | Multifibren UKQJ · Traditional | Behring Diagnostics, Inc. | 04/19/1994SE |
| K931721 | Il Test Fibrinogen-CKQJ · Traditional | Instrumentation Laboratory CO | 08/13/1993SE |
| K922416 | Fibrinogen Rid Test KitKQJ · Traditional | The Binding Site, Ltd. | 03/09/1993SE |
| K925988 | MultifibrenKQJ · Traditional | Behring Diagnostics, Inc. | 03/01/1993SE |
| K923593 | Hemochron/Factor Vi Fibrinogen Assay and Cont PlasKQJ · Traditional | International Technidyne Corp. | 09/22/1992SE |
| K920258 | QBC FibrinogenKQJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/26/1992SE |
| K900939 | SPQ Test System II for Fib (Serum Protein Quanti.)KQJ · Traditional | Incstar Corp. | 05/16/1990SE |
| K900895 | Coag-A-Mate - RA4KQJ · Traditional | Organon Teknika Corp. | 04/16/1990SE |
| K896052 | Fibrinogen Assay KitKQJ · Traditional | Medical Diagnostic Technologies, Inc. | 11/09/1989SE |
| K884179 | Turbox FibrinogenKQJ · Traditional | Unipath , Ltd. | 12/20/1988SE |
| K841366 | Dia FibrinKQJ · Traditional | Diatech, Inc. | 06/01/1984SE |
| K841020 | Fibrinogen Assay KitKQJ · Traditional | Helena Laboratories | 05/02/1984SE |
| K840211 | Fibri-Prest Automate HA34KQJ · Traditional | Wellcome Diagnostics | 03/02/1984SE |
| K834571 | Fibrinogen TestKQJ · Traditional | Diatech, Inc. | 02/04/1984SE |
| K812629 | Aca Fibrinogen Test PackKQJ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/08/1981SE |
| K812570 | Labcer Fibrinogen Assay Kit & Calibr.KQJ · Traditional | Sherwood Medical Co. | 10/02/1981SE |
| K812108 | Low Fibrinogen ControlKQJ · Traditional | Bio/Data Corp. | 09/24/1981SE |
| K811069 | Fibrinogen Control PlasmaKQJ · Traditional | American Dade | 07/10/1981SE |
| K810058 | Ortho Quantitative Fibrinogen AssayKQJ · Traditional | Ortho Diagnostic Systems, Inc. | 02/26/1981SE |
| K801926 | Sigma Procedure #880 Fibrinogin/PlasmaKQJ · Traditional | Sigma Chemical Co. | 09/09/1980SE |
| K800826 | Fibrinogen ScreenKQJ · Traditional | Pacific Hemostasis | 05/30/1980SE |
| K792563 | Thrombokinetic Fibrinogen AssayKQJ · Traditional | Bio/Data Corp. | 01/11/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2476-2025 Class II | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended…Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. | Diagnostica Stago, Inc. | 07/21/2025Open, Classified |
| Z-2763-2017 Class II | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5…An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number… | Fisher Diagnostics | 05/19/2017Terminated |
| Z-2762-2017 Class II | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations)…An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number… | Fisher Diagnostics | 05/19/2017Terminated |